A Study of Rifabutin, Used Alone or With Ethambutol in the Prevention of Mycobacterium Avium Complex (MAC) Bacteremia in Patients With AIDS
To optimize Mycobacterium avium Complex (MAC) prophylaxis in AIDS patients by measuring serum rifabutin levels and adjusting the dose accordingly. To combine rifabutin with ethambutol to examine the effect of combination therapy in preventing or delaying the incidence of MAC bacteremia in this patient population.
Patients are randomized to receive oral rifabutin alone or rifabutin/ethambutol daily for 12 months, with possible continuation of medicine lifelong. Doses will be adjusted to maintain minimum blood levels of the drugs.
Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Primary Purpose: Treatment
Mycobacterium Avium-Intracellulare Infection
Ethambutol hydrochloride, Rifabutin
Univ of California - Davis Med Ctr / CARES
NIH AIDS Clinical Trials Information Service
Results (where available)
- Source: http://clinicaltrials.gov/show/NCT00002343
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Mycobacterium Avium-intracellulare Infection
A nontuberculous infection when occurring in humans. It is characterized by pulmonary disease, lymphadenitis in children, and systemic disease in AIDS patients. Mycobacterium avium-intracellulare infection of birds and swine results in tuberculosis.
A broad-spectrum antibiotic that is being used as prophylaxis against disseminated Mycobacterium avium complex infection in HIV-positive patients.
Mycobacterium Avium Complex
A complex that includes several strains of M. avium. M. intracellulare is not easily distinguished from M. avium and therefore is included in the complex. These organisms are most frequently found in pulmonary secretions from persons with a tuberculous-like mycobacteriosis. Strains of this complex have also been associated with childhood lymphadenitis and AIDS; M. avium alone causes tuberculosis in a variety of birds and other animals, including pigs.
So-called atypical species of the genus MYCOBACTERIUM. They are also called tuberculoid bacilli, i.e.: M. buruli, M. chelonae, M. duvalii, M. flavescens, M. fortuitum, M. gilvum, M. gordonae, M. intracellulare (see MYCOBACTERIUM AVIUM COMPLEX;), M. kansasii, M. marinum, M. obuense, M. scrofulaceum, M. szulgai, M. terrae, M. ulcerans, M. xenopi.
A semi-synthetic macrolide antibiotic structurally related to ERYTHROMYCIN. It has been used in the treatment of Mycobacterium avium intracellulare infections, toxoplasmosis, and cryptosporidiosis.
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